The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
We intend to conduct a phase III b trial to verify Oxcarbazepine's effect in agitation and
aggression in patients with dementia. We designed the study as a randomized, double-blind,
placebo-controlled multi center trial. Hundred patients will be included. The treatment
period will be eight weeks, with a further follow up of four weeks.
The primary outcome measure will be the reduction in aggression and agitation as measured by
means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home
Version). Secondary outcomes are reduction in aggression as measured by BARS (Behavior
Agitation Rating Scale)and reduction in the burden to health-care personnel as measured by
NPI-NH.